An injection is an infusion method of putting fluid into the body, usually with a hollow needle and a syringe which is pierced through the skin to a sufficient depth for the material to be forced into the body. There are several methods of injection or infusion, including intradermal, subcutaneous, intramuscular, intravenous, intraosseous, intraperitoneal, and intraocular. Injections are among the most common health care procedures, with several billion administered each year. 95% of injections are administered in curative care, 3% for immunization and the rest for other purposes, such as blood transfusions. Some types of injections, such as intraocular injections, may benefit from the use of various devices to assist a medical professional (e.g., a doctor, a surgeon, a nurse, a medical technician, etc.) performing the injection. These devices are typically used to allow uninterrupted injection into a designated injection location. In case of intraocular injections, eyelid speculum(s) can be used to prevent a patient from blinking and interfering with the injection into the patient's eye.
Injections can be performed using a syringe-type device (which can include a hollow reservoir for containing an injection fluid and having a plunger configured to (via application of an external force) push the injection fluid through a needle coupled to the hollow reservoir and into the injection site), a catheter-type device, or any other device and can involve a penetration of a surface (e.g., skin, membranes, etc.) at the site of the injection. In view of such penetration, some injections can carry a risk of an infection either during and/or after the injection. For example, an intraocular injection of fluid can carry a risk of an intraocular infection after the injection through contamination of a needle used to perform such injection.
In 2008, over 1,017,000 intravitreal (“IV”) injections were given to patients, which are up from 533,000 injections in 2007. This number has been increasing in recent years due in large part to the effectiveness of injection drugs, such as AVASTIN®, LUCENTIS® and most recently Eylea®. Many studies have been performed looking at the incidence of infection following these IV injections and the average incidence has been found to be approximately 0.05%, though this can range anywhere from 0% to 1% depending on the study. While this is a small fraction of the total, the outcomes for patients who develop some form of intraocular infection is usually not good and commonly results in a significant and permanent loss of vision.
As part of an injection procedure when the medication does not come in a prefilled syringe, the medication needs to be drawn up from a vial containing the drug. These vials can come in various sizes and shapes, and typically have a rubber like stopper attached to the top of the bottle. The drug is typically drawn up with a needle that is attached to a syringe. In some cases the needle will have a filter inside it to prevent any of the stopper or other contaminants from getting into the syringe and being injected. The needle used to draw up the drug is then typically discarded, and a new needle is placed on the syringe for injection of the drug/medication.
While there are covered needles in use today, such as the ones used in combination with vacutainers, they are not practical for direct use with patients or drug filled containers. They are one piece, opaque, and require significant force in order to displace them. They lack the features ideal for injections into humans or animals. Such features would include the means to minimize the forces required to keep them safe, and to minimize discomfort. Visualization of the needle is also preferred so its location is known at all times, which is achieved through the use of transparent or clear plastics or materials in most cases. Addition of color to the clear plastic so that a transparent colored sleeve can be helpful to enhance visualization of the sleeve over or next to human or animal tissue. It is also preferable to keep the materials thin, so that they do not interfere with other devices that reduce the risk of needle stick to health care personnel.
Hence, there is a need for a system, a method, and/or a device configured to reduce the incidence of contamination when a drug is drawn up and infection during the injection into tissue. Such injection system, method, and/or device can also be configured to reduce and/or eliminate a need for an injection assistance device such as a lid speculum to hold the lids open in the case of an intraocular injection, as well as protect sterility of an injection device's components (e.g., a needle). These can also be configured to increase patient comfort during and/or after an injection and to protect needles from causing or spreading infections in other areas such as intravenous tubing or other medical devices as well as to help insure proper placement of the needle for insertion into an injection site relative to another structure near the injection site.